Clinical Trial: PregSource: Crowdsourcing to Understand Pregnancy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational [Patient Registry]

Official Title: PregSource: Crowdsourcing to Understand Pregnancy, Observations of Daily Living From Pregnant Women

Brief Summary: PregSource uses a crowd-sourcing approach, asking pregnant women to enter information regularly and directly about their pregnancies throughout gestation and the early infancy of their babies into online surveys and trackers via a website and/or mobile application ("app"). In exchange, participants can track their data over time, print out reports to share with their healthcare team, and see how they compare to other women. In addition, PregSource will provide participants with links to trusted, evidence-based information about pregnancy management, issues, and complications.

Detailed Summary:

The objective of PregSource: Crowdsourcing to Understand Pregnancy (PregSource) is: to better understand the range of physical and emotional experiences and alterations in behavior that women have during pregnancy and after giving birth, the impact of these experiences on women's lives, and the perinatal challenges encountered by special sub-populations of women.

PregSource uses a longitudinal, crowd-sourcing, citizen science approach, asking pregnant women regularly and directly about their pregnancies. Participants enter information throughout gestation and the early infancy of their babies into online surveys and trackers via a website and/or mobile application ("app"). In exchange, participants will be able to track their pregnancy data over time, print out reports to share with their healthcare team, and view summaries of de-identified data to see how they compare to other women. In addition, PregSource will provide participants with links to trusted, evidence-based information from partner organizations about pregnancy management, issues, and complications.

Participants may also be a potential pool of recruits for clinical studies. Based on information they enter, eligible women who are interested in participating in clinical studies may be sent contact information about observational or interventional studies. Their contact information will not be shared directly with researchers.

After a critical mass of data is collected, de-identified data will be available to approved researchers for analysis.


Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Current Primary Outcome: Number of women delivering at each gestational week [ Time Frame: Up to 44 weeks gestational age ]

Gestational age at pregnancy end date


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Birthweight of baby [ Time Frame: At delivery ]
    Birthweight of babies born >20 weeks gestational age
  • Maternal weight gain in pregnancy by gestational age [ Time Frame: Up to 44 weeks gestational age ]
    Maternal weight gain in pregnancy by gestational age
  • Number of women without pregnancy complications [ Time Frame: Up to 44 weeks gestational age ]
    Pregnancy complications including: gestational diabetes, preeclampsia, placenta previa, etc.)
  • Number of live births [ Time Frame: At birth ]
    Number of infants born alive


Original Secondary Outcome: Same as current

Information By: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Dates:
Date Received: October 5, 2015
Date Started: November 2016
Date Completion: September 2017
Last Updated: September 23, 2016
Last Verified: June 2016